To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

Bacterial Infections Clinical Trial

Official title:

Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402713
• Other study ID #: GC1107_P2/3
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 25, 2011
• Last updated: January 23, 2015
• Start date: August 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2015
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children

Description:

Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• healthy Korean children(age: 10 ~ 17)

• In the case of step1 (for step 1) 11~12 years

• who got the basic vaccination(5 times vaccination of diphtheria and tetanus until 6 years old.)

• Subjects willing to provide written informed consent and able to comply with the requirements for the study or informed consent was obtained from the subject's legal guardian

Exclusion Criteria:

• Subjects with antitoxin of diphtheria and tetanus =1.0IU/mL (ELISA)

• only applicable in step 1

• subjects who have not recovered from the acute disease within 2 weeks

• who has experienced the temporary platelet decrease or has the medical history of neurologic complication

• who has the medical history of allergic disease related to the components of investigational drug

• who has experienced the severe adverse events for the diphtheria and tetanus vaccination

• who got the vaccination of diphtheria and tetanus within 5 years

• who has not recovered from the acute disease within 2 weeks

• who got the treatment of blood product within 3 months

• who got the immunoglobulin should have the wash-out period

• who be infected from the diphtheria and tetanus

• Subjects who are scheduled to participate in other clinical trial studies during the study.

• Current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine.

• Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study

• Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment

• Subjects with a history of chronic disease obstacles to the study.

• Subjects who have episode of acute febrile (at least 37.5) after injection of vaccine during the study

• Subject who have plan of operation during the study.

• Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Biological:
• GC1107
GC1107-T5.0: low dose, GC1107-T7.5: high dose
• TD_PUR INJ / SK Td vaccine
step 1(phase 2)-TD_PUR INJ step 2(phase 3)-SK Td vaccine

Locations

Country	Name	City	State
Korea, Republic of	The catholic university of Korea, Seoul st. mary's hospital	Banpo-dong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step I-the seroprotection rate of diphtheria and tetanus	Number of participants after vaccination as a measure of the effectiveness	28 days	No
Primary	Step II-to assess noninferior of diphtheria and tetanus		28 Days	No
Secondary	StepI-GMT of diphtheria and tetanus		28 days	No
Secondary	Step I-safety assessment-solicited adverse event		42 days	Yes
Secondary	Step II-GMT of diphtheria and tetanus		28 days	No
Secondary	Step II-safety assessment-solicited adverse event		28 days	Yes
Secondary	Step II- Boosting response of diphtheria and tetanus		28	No